New range of sterile and filtered cleanroom disinfectants

Shield Medicare Company Profile

Shield Medicare is a market leader in the supply of specialistcontamination control products to pharmaceutical, biotechnology,healthcare and medical device industries worldwide.

Experienced cGMP manufacturer

• 15 years experience of high quality cleanroom manufacture to cGMP standards.

• Technical expertise, extensive processing capability and a well-deserved reputation

for innovation, proven by awards from the cleanroom industry.

• Operation of Grade C cleanrooms and Grade B aseptic suites.

Fully accredited

• BS EN ISO 9001:2000 and BS EN ISO 13485:2003 accredited and holds the Medical Device

Directive 93/42/EEC for the design, manufacture and distribution of sterile and non-sterile

cleanroom products.

• Working towards 98/8/EC Biocidal Product Directive.

• Regularly audited by the major pharmaceutical companies, who themselves have GMP

accreditation. Any customer is welcome to visit the sterile manufacturing facilities to

carry out a supplier audit.

Technical support available

• Specialist testing and quality laboratories operating to the principles of Good Laboratory Practice.

• Expertise and high levels of technical support through all stages of the specification and

validation process.

• Product range available across the world through a network of carefully appointed distributors.

Shield Medicare is a division of

Preserving cleanroom integrity demands the safe delivery of disinfectants,something often overlooked when using sterile disinfectants.

There are advantages to using trigger sprays to apply disinfectants, but not all trigger sprays

protect the sterility of the contents. With a conventional trigger spray, contaminated air can

be sucked back into the bottle, contaminating the liquid.

The patented SteriShield Delivery System solves this problem because it operates as a closed

system, preventing air being drawn back into the bottle and so eliminating the possibility

of contaminating the liquid.

• The liquid is held inside a medical

grade bag and all points of entry into

the bag, including the dip-tube, are

completely sealed.

• The system allows all the liquid to

be dispensed from the bottle so

there is no wastage.

• The adjustable trigger nozzle allows

the liquid to be dispensed as

a jet or a spray for optimum

surface coverage.

• The system has been independently

and rigorously validated to give

an in-use shelf life of three months,

so unused product does not need

to be discarded.

Full validation test data is available in technical report TR0403R.

A product using the SteriShield Delivery System is designated by

“Validation work in the licensed pharmacy unitof the Queen Elizabeth Hospital in Birmingham, UK, identified that a standard trigger spray alcohol had been contaminated with fungalspores only eight hours after opening.”Contamination Control at Your Fingertips, Pharmaceutical Manufacturing International, Autumn 1999

Preventing Spore Contaminationfrom Disinfectants

“

Selecting the right disinfectants

Whichever disinfectants you select for your contamination controlregime, they must be able to maintain the low levels of microbialcontamination predefined for each class of cleanroom, according to EU standards.

Many disinfectants have a broad spectrum of activity, especially against bacteria, but most

are not effective against spores, so choosing the right sporicide is particularly important.

Some disinfectants are so aggressive that they are harmful to health or equipment and unpleasant

for operators to use.

Shield Medicare disinfectants (biocides) are safe to use, effective and fast acting. They are

compatible with alcohols, offering a wide range of options for rotation to meet each cleanroom’s

individual requirements. Standard best practice of a disinfect, wipe and rinse routine should always

be used and note should be taken of the safety datasheet which gives conditions and chemicals to

avoid for each product.

Recommended limits for microbial contamination*

Settle Plates Contact Plates Glove PrintAir Sample (diam. 90 mm). (diam. 55 mm). 5 fingers

Grade cfu/m3 cfu/4 hours cfu/plate cfu/glove

A < 1 < 1 < 1 < 1

B 10 5 5 5

C 100 50 25 –

D 200 100 50 –

“cGMP states that “Disinfectants used in Grade A and B areas should besterile prior to use”.‡”* ‡ Eudralex Vol 4 Good Manufacturing Practice, Annex 1: “Manufacture of sterile medicinal products”“

How to choose disinfectants

Every application has different requirements, so consider:

• What grade of cleanroom you are operating and therefore what microbial reduction is required.

• Which organisms are a problem, based on your environmental test results.

• Rotation of disinfectants to ensure all organism types are removed and to eliminate any

risk of resistance.

• Whether a sporicide should be part of the rotational regime or for occasional action

point use only.

• Contact time required to achieve desired kill and whether you can afford significant

production down-time.

• Whether residues are acceptable.

• The safety of the disinfectant, eg toxic or corrosive.

• Whether the disinfectant is certified sterile and whether the disinfectant will remain

sterile during use.

• Range of formats available, for example ready-to-use fluids, concentrate, impregnated wipes,

mopping systems.

• Convenience and time taken to dilute concentrate solutions.

Broad spectrum efficacy with sporicidal activity

Fast acting, high quality disinfectants for cleanrooms and critical areas. The range will effectively

control all types of microbial contamination, including troublesome spores.

CEN and isolate tested

Comprehensive test data is available.

Safe and effective

Shield Medicare biocides are all non-toxic and non-corrosive under normal use, so they can

be used safely in most cleanroom environments.

Ideal for a rotational regime

Tested for compatibility, so no need for additional testing.

Suitable for Grade A and B areas

Cleanroom processed and sterile. Double bagged for easy transfer.

Guaranteed spore free

All sterile biocides, except Biocide S and Biocide T, are filtered to 0.2 micron and all are either

gamma irradiated or aseptically processed to a validated procedure.

Helpful validation documentation

A comprehensive technical file is available for each biocide, to shorten the validation process.

Range of presentations for ease of use

The biocides are available in a range of formats to suit different applications,

including trigger sprays, concentrates and impregnated wipes.

Unique SteriShield Delivery System

All trigger sprays incorporate Shield Medicare’s unique

SteriShield Delivery System, which ensures the contents

remain sterile throughout use.

Cleanroom friendly packaging

The packaging materials are low particulate and are easy

to spray and wipe for efficient transfer into clean areas.

Advantages of Biocides

Broad Spectrum Biocides

Shield Medicare offers a unique range of broad spectrum biocides in avariety of ready-to-use or concentrate formats, including impregnated wipes.

Premier Klercide-CR Biocide A is a blend of a quaternary ammonium compound and a biguanide

in a 1 litre trigger spray, 5 litre ready-to-use or 5 litre concentrate. Premier Klercide-CR BiocideX is a unit dose concentrate of the same formulation, to conveniently make up 5 litres of ready-to-

use product and reduce the risk of dilution errors. Both products are available sterile or filtered.

Premier Klercide-CR Biocide D is a sterile amphoteric surfactant in a 1 litre trigger spray,

5 litre ready-to-use or 5 litre concentrate. Premier Klercide-CR Biocide Y is a unit dose

concentrate of the same formulation, to conveniently make up 5 litres of ready-to-use product

and reduce the risk of dilution errors. Biocide Y is available sterile or filtered.

These four biocides are fully compatible with each other and suitable for rotation with alcohol.

They are 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom.

For sterile product, the bottles are then gamma irradiated. They have a 2 year shelf life.

Premier Klercide-CR Biocide T is a sterile unit dose concentrate containing glucoprotamin®,

a unique chemical formulation that is especially effective against bacteria. It makes up 8 litres

of ready-to-use product and reduces the risk of dilution errors. It is packaged in a Grade D (ISO

Class 8) cleanroom in aluminium laminated polyethylene sachets which are double bagged and

then gamma irradiated. It has a 2 year shelf life.

Suggested cleaning and disinfection regime

Frequently, useneutral detergent to

clean the areafollowed by alcohol

to disinfect.

Regularly, use a rotationof broad spectrum

disinfectants

If a specific spore problem

is identified: useBiocide B or E toremove spores.

The success of any contamination control regime is dependent on a range of environmental

and operational factors and every facility must validate its own procedures to ensure it

is meeting the cGMP guidelines for microbial limits, making adjustments as necessary.

One of the most difficult requirements in a life science cleanroom is thecontrol of bacterial spores, which are particularly difficult to killbecause they can lie dormant for long periods.

Spores can enter the cleanroom on people and on components at

a surprisingly high rate. Research has shown that around 40% of

consumables are contaminated with bacterial spores. The study

also showed that if the transfer disinfection procedure employed

comprised of spraying solely with alcohol, only 27.6% of the

spores would be removed, so the regular use of a sporicide should

be strongly considered.

Shield Medicare can offer a range of sporicidal disinfectants suitable

for all areas of the cleanroom and to meet different sporicidal needs. They are excellent for routine

spore prevention, or the more powerful sporicides, Biocide B and E, are suitable for action point

use to remove troublesome spores.

Features of Shield Medicare sporicides:

• Proven efficacy against a wide range of spores.

• Passes standard CEN tests for sporicidal activity - comprehensive test data is available.

• Short contact time (5 - 15 mins) even in conditions of heavy soiling.

• Non-toxic and non-corrosive under normal use.

Premier Klercide-CR Biocide B is a broad spectrum disinfectant with excellent sporicidal

activity. It is a unique blend of a stabilised chlorine dioxide and a quaternary ammonium compound.

It is safe and pleasant to use and due to its faint odour it has high operator acceptance.

It is 0.2 micron sterile filtered and double bagged under laminar flow in a Grade B (ISO Class 5)

cleanroom. It is also available non-sterile, filtered to 0.2 micron in a Grade C (ISO Class 7)

cleanroom and double bagged. 1 year shelf life for ready-to-use, 9 months for concentrate.

Premier Klercide-CR Biocide B is available in a range of formats so is ideal for use in all areas

of the cleanroom, including a ready to use trigger spray, concentrate solution for bucket systems,

impregnated pouch wipes, or mop wipes.

Alcohol does not kill

spores

Effective Sporicides

Effective Sporicides

Premier-WFI Klercide-CR Biocide C is a 6% spray grade hydrogen peroxide solution blended

with Water for Injection, specifically designed for areas where a low level, safe sporicide with

very low residues is required. Endotoxin levels are guaranteed to be below 0.25 EU/ml, making

this sporicide ideal for product contact areas, isolators and RABS. It is available in a 1 litre trigger

spray and 5 litre ready-to-use, triple bagged for the highest grade areas.

Alternatively it is available blended with deionised water, Premier Klercide-CR Biocide C, in a

1 litre trigger spray and 5 litre ready-to-use, double bagged. Both products are 0.2 micron sterile

filtered in a Grade B (ISO class 5) cleanroom and have a 1 year shelf life.

Premier Klercide-CR Biocide E is an effective ready to use sporicide, a sodium hypochlorite

solution providing 0.5% available chlorine. Particularly suitable where high level sporicidal activity is

required at short contact times, it is available in a 1 litre trigger spray or 5 litre ready

to use. It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom

before gamma irradiation. It has a 2 year shelf life.

Premier Klercide-CR Biocide S is a unit dose concentrate, also based on 0.5% available

chlorine, supplied in tablet form for safety and ease of handling. The concentrate consists of

a pot of 17 tablets of sodium dichloroisocyanurate (NaDCC) in an effervescent base, which form

a solution containing 0.5% (5000 ppm) available chlorine when diluted in 10 litres of water. Each

tablet contains 5 g NaDCC in a total tablet weight of 10 g. Each pot of tablets is double bagged in

a Grade D (ISO Class 8) cleanroom and gamma irradiated. It has a 2 year shelf life.

Validation

All products are supplied by a BS EN ISO 9001:2000, BS EN ISO 13485:2003 and European

Medical Device Directive 93/42/EEC accredited company.

Certificates of analysis, irradiation and sterility (as appropriate) available with every batch.

Sterility tested to an approved pharmacopoeial method.

Full supporting documentation available for all biocides.

Efficacy of Biocides

Efficacy against a selection of organisms typically found in a pharmaceutical cleanroom*

Spores No Efficacy Good Fair No Efficacy Good No EfficacyBacillus cereus

Bacillus coagulans

Bacillus licheniformis

Bacillus pumilis

Bacillus sphaericus

Bacillus subtilis var.niger

Bacillus subtilisBacteria Good Good Good Good Good GoodClostridium botuliniumClostridium perfringensCorynebacterium speciesEnterococcus faeciumEnterococcus hiraeEscherichia coliGemella morbillorumKlebsiella pneumoniaeKytococcus sendentariusListeria monocytogenesMicrococcus luteusMycobacterium smegmatisMycobacterium tuberculosisProteus mirabilisPseudomonas aeruginosaSalmonella choleraesuisSalmonella entiritidisSerratia liquefaciensSerratia marcescensStaphylococcus aureusStaphylococcus capitisStaphylococcus epidermidisStaphylococcus hominisStaphylococcus simulansVancomycin res. Enterococci

Fungi Fair Fair Fair Fair Good FairAbsidia corymbifera

Aspergillus fumigatus

Aspergillus niger

Candida albicans

Cladiosporium cladosporioides

Mucor racemosum

Penicillium compactum

Penicillium expansum

Penicillium notamumSaccharomyces rouxiiTricophyton interdigitaleViruses Fair Good Good Fair Good FairHepatitis BHerpes HSV-2HIVHong Kong Virus 68Influenza A2PoliovirusRhinovirus

Key

Results fromEN1040,EN1276,EN1650,EN13704,EN13697and ShieldMedicare HardSurface Test

Results fromother laboratorytesting

Anecdotalevidence

* This is not an exhaustivelist, but givesan indicationof efficacyagainstdifferentorganismtypes. Eachinstitutionmust validate a disinfectantto ensureefficacyagainst its specificwild isolates.

Biocide A/X Biocide B Biocide C BiocideD/Y

Biocide E/S Biocide T

Shield Medicare Ltd cannot assume responsibility for product performance as the wide areas of use are beyond our control. ShieldMedicare Ltd makes no guarantees, specific or implied, for the suitability of use. Purchasers and Users should verify that products aresuitable for the intended purpose. The product range is continually being updated and improved, we therefore reserve the right to change,modify or withdraw any product or service without notice.

Ordering Information

KCR4241 Premier Klercide-CR Sterile Biocide A Spray 1.0 litre 6 bottles x 1.0 litre

KCR4251 Premier Klercide-CR Sterile Biocide A Capped 5.0 litre 4 bottles x 5.0 litre

KCR812 Premier Klercide-CR Sterile Biocide A Concentrate Capped 5.0 litre 4 bottles x 5.0 litre

KCR701 Klercide-CR Biocide A Spray 1.0 litre 6 bottles x 1.0 litre

KCR751 Klercide-CR Biocide A Capped 5.0 litre 4 bottles x 5.0 litre

KCR8103 Klercide-CR Biocide A Concentrate Capped 5.0 litre 4 bottles x 5.0 litre

KCR722 Premier Klercide-CR Sterile Biocide X Unit Dose Concentrate 50 ml 50 bottles x 50 ml

KCR711 Klercide-CR Biocide X Unit Dose Concentrate 50 ml 50 bottles x 50 ml

WPK2515 Klerwipe-CR Sterile Biocide A Low Particulate Pouch Wipe 200 x 200 mm 20 packs x 15 wipes

WPM5015 Klerwipe-CR Sterile Biocide A Low Particulate Mop Wipe 420 x 250 mm 10 packs x 20 wipes

KCR4242 Premier Klercide-CR Sterile Filtered Biocide B Spray 1.0 litre 6 bottles x 1.0 litre

KCR4253 Premier Klercide-CR Sterile Filtered Biocide B Capped 5.0 litre 4 bottles x 5.0 litre

KCR814 Premier Klercide-CR Sterile Filtered Biocide B Concentrate Capped 5.0 litre 4 bottles x 5.0 litre

KCR705 Klercide-CR Biocide B Spray 1.0 litre 6 bottles x 1.0 litre

KCR755 Klercide-CR Biocide B Capped 5.0 litre 4 bottles x 5.0 litre

KCR8105 Klercide-CR Biocide B Concentrate Capped 5.0 litre 4 bottles x 5.0 litre

WPK2525 Klerwipe-CR Sterile Filtered Biocide B Low Particulate Pouch Wipe 200 x 200 mm 20 packs x 15 wipes

WPM5025 Klerwipe-CR Sterile Filtered Biocide B Low Particulate Mop Wipe 420 x 250 mm 10 packs x 20 wipes

KCW6243 Premier-WFI Klercide-CR Sterile Filtered Biocide C Spray 1.0 litre 6 bottles x 1.0 litre

KCW6255 Premier-WFI Klercide-CR Sterile Filtered Biocide C Capped 5.0 litre 4 bottles x 5.0 litre

KCR4243 Premier Klercide-CR Sterile Filtered Biocide C Spray 1.0 litre 6 bottles x 1.0 litre

KCR4255 Premier Klercide-CR Sterile Filtered Biocide C Capped 5.0 litre 4 bottles x 5.0 litre

WPK2535 Klerwipe-CR Sterile Filtered Biocide C Low Particulate Pouch Wipe 200 x 200 mm 20 packs x 15 wipes

WPM5035 Klerwipe-CR Sterile Filtered Biocide C Low Particulate Mop Wipe 420 x 250 mm 10 packs x 20 wipes

KCR4244 Premier Klercide-CR Sterile Biocide D Spray 1.0 litre 6 bottles x 1.0 litre

KCR4257 Premier Klercide-CR Sterile Biocide D Capped 5.0 litre 4 bottles x 5.0 litre

KCR818 Premier Klercide-CR Sterile Biocide D Concentrate Capped 5.0 litre 4 bottles x 5.0 litre

KCR725 Premier Klercide-CR Sterile Biocide Y Unit Dose Concentrate 50 ml 50 bottles x 50 ml

KCR714 Klercide-CR Biocide Y Unit Dose Concentrate 50 ml 50 bottles x 50 ml

WPK2545 Klerwipe-CR Sterile Biocide D Low Particulate Pouch Wipe 200 x 200 mm 20 packs x 15 wipes

WPM5045 Klerwipe-CR Sterile Biocide D Low Particulate Mop Wipe 420 x 250 mm 10 packs x 20 wipes

KCR4245 Premier Klercide-CR Sterile Biocide E Spray (Chloroclens) 1.0 litre 6 bottles x 1.0 litre

KCR4259 Premier Klercide-CR Sterile Biocide E Capped (Chloroclens) 5.0 litre 4 bottles x 5.0 litre

KCR718 Premier Klercide-CR Sterile Biocide S Concentrate Tablets (Chloroclens) 170 g 12 tubs x 170 g

KCR720 Premier Klercide-CR Sterile Biocide T Concentrate (Inciclens) 20 ml 60 sachets x 20 ml

KFS005 Klercide Fogging System – Each

KPSS20 Klercide Pressurised Spray System – Each

Code Description Size Unit of Sale

Shield Medicare Ltd Cheyenne House West Street Farnham GU9 7EQ UKTel: +44 (0)1252 717616 Fax: +44 (0)1252 715269 info@shieldmedicare.com www.shieldmedicare.com

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